Biotech Values

[DewDiligence]

Re: M402’s probability of regulatory success

I heard Dew wrote a letter to MNTA's management telling them that oncology was a sucker's bet. (Jus kiddin...LOL)

I didn’t do that, but I did try to answer a question about M402’s probability of regulatory success posed by another poster. My answer (reposted from #msg-77165271):

We don’t have a lot of M402-specific data to go on, so we’ll have to resort to using industry averages as benchmarks and tweak them as we deem appropriate.

The cumulative probability of regulatory success for a drug entering phase-1 is 9% according to a recent study by BIO (#msg-60339665, #msg-59909806). For the lead indication of a drug, the probability is somewhat higher (#msg-60340131); on the other hand, for oncology, the probability is somewhat lower than in other areas (#msg-60340768). (The chart in #msg-60340768 does not list pancreatic cancer, specifically, but I would surmise that it ranks closer to the bottom than the top.)

The regulatory success rate is higher for biologics (15%) than for small-molecule drugs (7%) (see #msg-59909806 about ¼ of the way down); M402 is neither a biologic nor a small molecule, but it arguably has more of the characteristics of the former than the latter.

Should any points be added to the regulatory-success probability of M402 based on MNTA’s proven technical knowhow with heparin-based drugs? Yes, I think so, but probably not a lot.

All told, therefore, I think a reasonably person can justify a regulatory-success probability in the 10-15% range. Optimists can probably get to a 20-25% figure based on MNTA’s track record, while pessimists who focus on the dire history of drug candidates in pancreatic cancer can arrive at a number in the single digits. Thus, there’s a wide of plausible figures, but I’m inclined to go with 10-15% for modeling purposes until more concrete data are available.

Feedback welcome.